NCT00002094

Brief Summary

To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to U-87201E. To determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in the presence of U-87201E will generate the resistant mutants that may subsequently emerge in the patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1993

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Virus ReplicationAcquired Immunodeficiency SyndromeAntiviral Agents

Interventions

Atevirdine mesylateDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have:
  • Enrollment on protocol RV-43 (AZT resistance study).
  • Development of a primary RV-43 study endpoint-opportunistic infection.
  • HIV isolate with an AZT IC50 \> 50 times that of the sensitive type strain.
  • Able to swallow tablets without difficulty.
  • Normal QTc interval on EKG.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine).
  • Severe uncontrollable diarrhea or vomiting or known malabsorption.
  • Symptomatic hyperlipidemia.
  • Concurrent Medication:
  • Excluded:
  • Other experimental drugs.
  • AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted).
  • Patients with the following prior conditions are excluded:
  • History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction.
  • Prior Medication:
  • Excluded:
  • Experimental drugs within 4 weeks prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natl Naval Med Ctr

Bethesda, Maryland, 208995000, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

atevirdine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1993-02

Locations

US(1)